Module 15 Presentations

10/04/2024

Clinical Investigations under MDR:

Kiren Ajab Clinical Services Operations Manager

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Agenda

• Types of clinical studies • Implication of MDR • ISO14155:2020 • Safety Reporting (MDR, MDCG & ISO) • Clinical strategy notification requirements. The role of the clinical team and regulatory governance • Data Protection • UK Submission Process – Post Brexit

The Organisation for Professionals in Regulatory Affairs

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